Vice President, Clinical Development

Responsibilities Development of Clinical Development strategy for all internal and external (partnered through licensing) programs, including timeline and cost estimates, inclusive of pre‑approval and post‑approval label‑expansion studies. Personnel management of full‑time employees who fill the roles of: Clinical Trial Manager, Data Manager, Clinical Project Manager and Clinical Program Manager. Personnel management of part‑time contractors who fill the roles of: biostatistician, Clinical Quality Manager, Medical Writing, Bioassay development, preclinical development, pharmacokinetics, clinical monitor / medical director (MD). Requirements Strong scientific and clinical development background spanning small molecules and biologic development in a broad range of therapeutic areas, including CNS, oncology, cardiovascular, anti‑infectives, GI, obesity, respiratory, and rare diseases. Strong understanding of 505(b)(2) and hybrid medicine approval pathways and the strategies to minimize approval requirements for clinical studies. Strong operational background in leading and managing the timelines and Phase I‑IV clinical trials globally. Strong communication skills and ability to lead and contribute to cross‑functional teams. Strong interpersonal skills to support, mentor and manage a high‑performing team of experienced clinical development professionals and related part‑time contractors. MD or Ph.D. in a basic or health‑related scientific discipline with related research and drug development experience, with an emphasis in late‑stage clinical development expertise (Preferred). Strong understanding of Clinical Regulatory (FDA, MHRA, ICH) guidelines and requirements, Clinical Quality and GCP regulations (Preferred). #J-18808-Ljbffr